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Riluzole and Lithium to treat Depression in Bipolar Disorder Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Riluzole and Lithium to treat Depression in Bipolar Disorder conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Riluzole and Lithium to treat Depression in Bipolar Disorder Clinical research trials and Riluzole and Lithium to treat Depression in Bipolar Disorder healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Riluzole and Lithium to treat Depression in Bipolar Disorder. Riluzole and Lithium to treat Depression in Bipolar Disorder Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Riluzole and Lithium to treat Depression in Bipolar Disorder clinical trial. Participants typically obtain the most effective healthcare available for their Riluzole and Lithium to treat Depression in Bipolar Disorder condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Riluzole and Lithium to treat Depression in Bipolar Disorder  Riluzole and Lithium to treat Depression in Bipolar Disorder
Riluzole and Lithium to treat Depression in Bipolar Disorder
For Condition: Bipolar Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) in combination with the lithium, a mood stabilizer, for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients. Patients between 18 and 80 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test. After screening, those enrolled in the study will be tapered off all psychiatric medications except lithium, and those who are not taking lithium will be started on the drug. Participants will then begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures: - Physical examination and electrocardiogram (EKG) at the beginning and end of the study; - Weekly check of vital signs (temperature, blood pressure and heart rate); - Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response; - Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects. At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged.
Details: The treatments for acute unipolar depression have been extensively researched. However, despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of depressed patients fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Very few studies have examined the efficacy of somatic treatments for the acute phase of bipolar depression. Thus, there is a clear need to develop novel and improved therapeutics for bipolar depression. Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system. It is noteworthy that lamotrigine reduces glutamatergic neurotransmission, has antidepressant effects in bipolar depression, and a pilot study has suggested that NMDA antagonists may have antidepressant effects. Together, this data suggests that the glutamatergic system may play a role in the pathophysiology and treatment of depression, and that agents, which more directly reduce glutamatergic neurotransmission, may represent a novel class of antidepressants. Riluzole, an agent that is FDA-approved for Amyotrophic Lateral Sclerosis has significant antiglutamatergic properties, may prove to have antidepressant properties in depressed patients. In this study, we propose to investigate the potential antidepressant efficacy of riluzole in bipolar depression, an agent which reduces glutamatergic throughput via inhibition of its release. This is an 8-week single-arm, single-blind add-on study that will examine the efficacy and safety of riluzole in combination with a mood stabilizer in acutely depressed bipolar patients. The study has two Study Periods. Study Period I is the washout phase that will last 7 days. Study Period II is an add-on 8-week acute treatment phase in which the efficacy and tolerability of riluzole is compared to baseline. Patients, ages 18 or older with a diagnosis of bipolar disorder I or II current episode depressed (without psychotic features), will in this pilot study (single arm, single-blind) receive riluzole (50-200 mg/day) for a period of 8 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 25 patients will enter the study to obtain 22 subjects who complete the 8 weeks of acute riluzole treatment. Therefore if 7/22 patients or greater have greater than 50% improvement on the primary efficacy measure, then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Male or female subjects, 18-80 years of age. Female subjects of childbearing potential must be using a medically accepted means of contraception. Each subject must have a level of understanding sufficient to agree to all required tests and examinations. Each subject must understand the nature of the study and must sign an informed consent document. Subjects must fulfill the criteria bipolar I or II disorder, current episode depressed without psychotic features as defined in DSM-IV based on clinical assessment and confirmed by structured diagnostic interview SCID-P. Subjects must have an initial score at Visit 1 and Visit 2 of at least 20 on the MADRS. Subjects must not have a decrease in the total score of MADRS of greater than or equal to 20% during washout (between Visits 1 and 2). Subjects must have experienced, in the opinion of the investigator, at least one previous major depressive episode as defined in DSM-IV (not including the current major depressive episode). Subjects must be on the therapeutic dose of lithium for 4 weeks prior to Visit 2. If the subject is not taking lithium, the research physician may start them on lithium at the NIH. EXCLUSION CRITERIA: Presence of psychotic features. Participation in a clinical trial of another investigational drug within 1 month (30 days) prior to study entry (visit 1). Female subjects who are either pregnant or nursing. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. Subjects with uncorrected hypothyroidism or hyperthyroidism. Abnormal levels of serum transaminases (ALT/SGPT); AST/SGOT), current or past blood dyscrasia. Documented history of hypersensitivity or intolerance to riluzole. DSM-IV substance abuse or dependence within the past 90 days. Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2. Treatment with a reversible MAOI, guanethidine, or guanadrel within 1 week or with fluoxetine within 6 weeks prior to Visit 2. Treatment with any other concomitant medication with primarily CNS activity, other than specified in Appendix A. Treatment with clozapine or ECT within 12 weeks prior to Visit 2. Current diagnosis of schizophrenia or other psychotic disorder as defined in the DSM-IV. Current Axis I Anxiety Disorder. Judged clinically to be at serious suicidal risk. Rapid cylers (greater than 6 DSM-IV mood episodes per year) in the past 12 months.
Total Enrollment: 25
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030092; 03-M-0092
Study Start Date: February 5, 2003
Record last reviewed: November 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054704
Other Bipolar Disorder Studies:
1. Treatment and Outcome of Early Onset Bipolar Disorder
2. Clozapine for Treatment-Resistant Mania
3. Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
4. Study of Aripiprazole in Patients with Bipolar I Disorder with a Major Depression Episode
5. The Assessment of a weight-gain agent for the Treatment of Olanzapine-Associated Anti-obesity Agent in Patients with Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
Related Studies:
Other Bipolar Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Riluzole and Lithium to treat Depression in Bipolar Disorder
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